Medical devices – Conformity assessment

Medical devices claim to provide patients with a medical treatment, a valuable service or offer relief and in either case are so safe that they do not cause any deterioration of the general state of health. The marketing of a product as a medical device is therefore tied to guidelines, which are published again in the region of the European Union as EC Directive 2007/47. There are standards comparable with the FDA guidelines in the USA.

In order to avoid the risk of a high fine, it is essential for a manufacturer or dealer to know and to satisfy the requirements when placing medical devices into circulation. However, medical devices are not always represented as such from the start. This is the case, for example, when the devices have other applications outside of medical applications and / or are used in combination with conventional medical devices.  Furthermore, there are numerous situations where even more guidelines apply. Aside from this there are restrictions to the definition, in the case of diagnostic products, for example, which are considered to be "in-vitro products". Ultimately, it is the intended use for the intended indication that is decisive for classification of a medical device. However, because this definition is flexible the area of medical devices has been flooded with products, which would really have more commonly been assigned to the wellness, cosmetics, nutrition, pharmaceuticals groups, etc.

As a notified body we are authorized to assess medical devices and the associated processes for manufacture and for trade in a particular field of activity and to issue a certificate of conformity to these devices to the extent that they satisfy the requirements. With a view to the confidence to act we are always first concerned with analyzing the workability with the applicant for a certificate of conformity. We will submit a quote and accept an order only when there is clarity.

With a view to the level of diversification in the indication and the application of medical devices we have at our disposal a broad spectrum of professional people, who we involve in a conformity assessment as needed depending on the medical device.  So we make sure that the claim of the patients mentioned at the outset is assured.